CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 88 enrolled
Drug / intervention
Tranexamic Acid +1 moredrug
Likely dose
Tranexamic Acid 10 mg/kgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02051686
NCT02051686N/ACompleted

Hemostasis in Open Acetabulum and Pelvic Ring Surgery Using Tranexamic Acid: A Prospective, Randomized, Controlled Study

University of Missouri-Columbia·interventional·Posted Jan 31, 2014·Updated Feb 27, 2018

In Brief

A clinical study evaluating Tranexamic Acid and Placebo for Acetabulum Fractures. Completed, enrolled 88 participants across 1 site.

Detailed Summary

This study is investigating the use of tranexamic acid (TXA) in patients with pelvis and/or hip socket fractures that require surgery. TXA is FDA-approved in patients with hemophilia for short-term use to reduce hemorrhage and the need for replacement blood during tooth extraction. However, it has also been used extensively in severely injured patients after major trauma and during elective hip and knee replacements. Previous studies indicate TXA may reduce blood loss and the need for blood transfusions while being safe for use in most patients. TXA is fairly inexpensive and easy to obtain. The purpose of this study is to determine if TXA will make surgery in patients with pelvis and/or hip socket fractures safer and more cost efficient.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedJan 31, 2014
Enrollment StartJun 1, 2013
Primary CompletionDec 1, 2016
TodayJul 2, 2026
Enrollment to primary: 3.5 yearsPosted 12.4 years ago

Interventions

Tranexamic Aciddrug

10 mg/kg TXA loading dose approximately 15 minutes before surgical start time and then 1 mg/kg/h TXA infusion over 10 hours.

Placebodrug

The control group will receive a similar volume load of normal saline and maintenance doses.